Argá Medtech Launches COHERENT-AF IDE Clinical Trial to Treat Atrial Fibrillation
Argá Medtech, a pioneer in electro-medical technologies, has officially commenced the enrollment process for its groundbreaking clinical trial known as COHERENT-AF. This pivotal trial is significant as it aims to investigate the safety and efficacy of the Coherent Sine-Burst Electroporation™ (CSE™) System, a next-generation pulsed field ablation (PFA) technology designed to treat patients suffering from cardiac arrhythmias like atrial fibrillation (AF). The COHERENT-AF trial is a prospective and non-randomized study sanctioned by the U.S. Food and Drug Administration (FDA) under the Investigational Device Exemption (IDE) program, and it plans to encompass a total of up to 360 participants across multiple clinical sites in the United States and Europe.
The first set of patients in this innovative trial was successfully treated by Dr. Ante Anic at KBC Split Hospital in Split, Croatia. Subsequent to the procedures, all participants demonstrated stable conditions and were discharged to continue their recovery at home. According to Dr. Anic, the unique flexibility of the CSE platform offers significant advantages, particularly when addressing conditions that extend beyond the standard pulmonary vein isolation approached for AF treatment. The multi-configurable, single stylet-driven ablation catheter not only simplifies the transition to deliver both linear and focal ablations, but also enhances procedural efficiencies, which is incredibly beneficial for treating individuals with both paroxysmal and persistent forms of AF. An additional safety measure is realized as this design reduces the frequency of catheter exchanges during procedures.
Preliminary results indicate promising efficacy, with the CSE system previously used in a cohort of over 100 patients. Data from this earlier BURST-AF clinical study revealed a remarkable lesion durability exceeding 94% at three months follow-up, a freedom from atrial arrhythmias of 92.6% at the six-month mark, and an impressively low adverse event rate of just 1.0%. David Neale, the CEO of Argá Medtech, expressed his enthusiasm about the initiation of COHERENT-AF, highlighting its role as a pivotal step in the company’s mission to offer a new and efficient ablation therapy to millions affected by AF and other cardiac rhythm disorders.
The CSE™ PFA platform stands out due to its proprietary design that combines a specialized CSE™ PFA generator with a versatile catheter. This unique system allows for an unprecedented flexibility when treating AF, permitting precise energy titration tailored to the specific depth of the cardiac tissue that needs ablation. The ability to generate either circular, linear, or focal lesions using the catheter without swapping instruments minimizes the risk of air bubbles during procedure transitions and simplifies the entire process while also cutting down on associated costs.
Atrial fibrillation is reported to be the most prevalent cardiac arrhythmia, with about 38 million individuals impacted globally. This condition significantly escalates the risk of stroke, making AF patients up to five times more susceptible to this serious event. While traditional thermal energy ablation has shown effectiveness in relieving AF symptoms, it poses risks of damaging adjacent tissues. In contrast, the pulsed field ablation technology employed by the CSE system is designed to selectively target heart tissue while sparing surrounding areas, thus preventing thermal injuries to critical structures like the esophagus and phrenic nerve.
As the COHERENT-AF trial progresses, Argá Medtech is set to establish new standards within the field by aiming for FDA approval of its innovative therapy. The leadership of the company combines over fifty years of expertise in the development and commercialization of cardiac and arrhythmia management products, positioning Argá Medtech as a frontrunner in addressing the challenges faced by patients and healthcare providers alike.
For more information on Argá Medtech and its revolutionary approach to cardiac arrhythmias, visit their official website at https//argamedtech.com.
The first set of patients in this innovative trial was successfully treated by Dr. Ante Anic at KBC Split Hospital in Split, Croatia. Subsequent to the procedures, all participants demonstrated stable conditions and were discharged to continue their recovery at home. According to Dr. Anic, the unique flexibility of the CSE platform offers significant advantages, particularly when addressing conditions that extend beyond the standard pulmonary vein isolation approached for AF treatment. The multi-configurable, single stylet-driven ablation catheter not only simplifies the transition to deliver both linear and focal ablations, but also enhances procedural efficiencies, which is incredibly beneficial for treating individuals with both paroxysmal and persistent forms of AF. An additional safety measure is realized as this design reduces the frequency of catheter exchanges during procedures.
Preliminary results indicate promising efficacy, with the CSE system previously used in a cohort of over 100 patients. Data from this earlier BURST-AF clinical study revealed a remarkable lesion durability exceeding 94% at three months follow-up, a freedom from atrial arrhythmias of 92.6% at the six-month mark, and an impressively low adverse event rate of just 1.0%. David Neale, the CEO of Argá Medtech, expressed his enthusiasm about the initiation of COHERENT-AF, highlighting its role as a pivotal step in the company’s mission to offer a new and efficient ablation therapy to millions affected by AF and other cardiac rhythm disorders.
The CSE™ PFA platform stands out due to its proprietary design that combines a specialized CSE™ PFA generator with a versatile catheter. This unique system allows for an unprecedented flexibility when treating AF, permitting precise energy titration tailored to the specific depth of the cardiac tissue that needs ablation. The ability to generate either circular, linear, or focal lesions using the catheter without swapping instruments minimizes the risk of air bubbles during procedure transitions and simplifies the entire process while also cutting down on associated costs.
Atrial fibrillation is reported to be the most prevalent cardiac arrhythmia, with about 38 million individuals impacted globally. This condition significantly escalates the risk of stroke, making AF patients up to five times more susceptible to this serious event. While traditional thermal energy ablation has shown effectiveness in relieving AF symptoms, it poses risks of damaging adjacent tissues. In contrast, the pulsed field ablation technology employed by the CSE system is designed to selectively target heart tissue while sparing surrounding areas, thus preventing thermal injuries to critical structures like the esophagus and phrenic nerve.
As the COHERENT-AF trial progresses, Argá Medtech is set to establish new standards within the field by aiming for FDA approval of its innovative therapy. The leadership of the company combines over fifty years of expertise in the development and commercialization of cardiac and arrhythmia management products, positioning Argá Medtech as a frontrunner in addressing the challenges faced by patients and healthcare providers alike.
For more information on Argá Medtech and its revolutionary approach to cardiac arrhythmias, visit their official website at https//argamedtech.com.
Topics Health）
【About Using Articles】
You can freely use the title and article content by linking to the page where the article is posted.
※ Images cannot be used.
【About Links】
Links are free to use.